Methods and systems to secure control and enhance medication adherence

ABSTRACT

Embodiments of the invention provide systems and methods to provide safe, secure and accurate point-to-point delivery of prescription and non-prescription drugs in the long-term home care or ambulatory care environment. More specifically, embodiments of the present invention provide for a low-cost, easy-to-use system comprised of a secure drug dispensing unit and medication enclosure combined with wireless connectivity and software based on smart mobile phone technology. Such systems and methods, referred to herein as a Secure, Control, and Enhance Medication Adherence (SCEMA) system, can mitigate the aforementioned risks associated with the use of prescription and non-prescription drugs. These risks can be significantly reduced for the elderly in the homecare environment, as well as the general public, without disrupting, or a significantly increasing the cost, to the existing prescription and non-prescription drug distribution infrastructure. In addition, the SCEMA system can provide a powerful platform for drug research.

CROSS-REFERENCES TO RELATED APPLICATIONS

The present application is a continuation application of U.S. patentapplication Ser. No. 13/854,199 filed on Apr. 1, 2013 by Fauci andentitled “Methods and Systems to Secure Control and Enhance MedicationAdherence,” which claims benefit under 35 USC 119(e) of U.S. ProvisionalApplication No. 61/619,545, filed on Apr. 3, 2012 by Fauci and entitled“Secure Control and Enhance Medication Adherence (SCEMA) Systems,” ofwhich the entire disclosures are incorporated herein by reference forall purposes.

BACKGROUND OF THE INVENTION

Embodiments of the present invention relate generally to methods andsystems for management of medications and more particularly to methodand systems to provide safe, secure and accurate point-to-point deliveryof prescription and non-prescription drugs.

Multiple, potential risks or complications that exist in theadministration of medicines are derived from patient, provider,pharmacy, and/or system level failures. These risks are significantlymitigated in the acute care setting through the use of automatedpharmacy technologies that include unit dose packaging systems thatmatch bar coded medication packets to patient's bar coded wrist bands,thereby establishing positive patient identification and electronicallyverifying the medication at the bedside. The same risks of medicationerrors found in the acute care setting are substantially magnified inthe home or ambulatory care setting due to the lack of similarpoint-to-point medication delivery technology, as well as the absence ofdirect medical supervision. These risks have been shown to lead toincreases in hospital readmission rates, long-term care admissions,morbidity and mortality events. According to the National Institute onDrug Abuse (NIDA), currently available technologies and methods toaddress these problems are inadequate.

One quarter of the prescription drugs sold in the United States are usedby the elderly, often for problems such as chronic pain, insomnia, andanxiety. Multiple potential risks or complications that ordinarily existin the administration of medicines in an institutionalized care settingare significantly magnified in the home care environment. If notadequately addressed and managed these risks have been shown to lead toincreases in morbidity and mortality. Home-based elderly are perhapsamong the most vulnerable population in this regard. For example,Medication Adherence (MA) by the elderly is often as low as 26% andcontributes to limiting the achievement of therapeutic goals. The oddsof good health outcomes are nearly three times lower for patients who donot adhere to recommended therapies than for patients who followprovider recommendations. Low MA increases patient and providerfrustration and can increase health care costs, including avoidablehospitalizations. For older adults, MA difficulties may account for 10to 25% of hospital and nursing home admissions, or re-admissions, andnot only exacerbates disease severity but can cause fatalities.Approximately 125,000 Americans die annually due to poor MA. Theestimated annual cost of patients not taking their medications asprescribed is approaching $290 billion.

Another overlapping issue is Adverse Drug Reactions (ADR), which someresearchers believe increases exponentially with the number ofmedications taken. ADR among the general population is estimated to bebetween the fourth and sixth leading cause of death in the U.S. Manystudies from around the world show a correlation between increasing ageand the ADR rate with the most recent studies indicating that the ADRrate for the elderly in the U.S. and Europe was 20% greater than instudies carried out in general medical settings.

Prescription Drug Diversion and Abuse (PDDA), are large and rapidlygrowing problems in the U.S. health care delivery system. Abuse ofseveral categories of prescription drugs has increased markedly in theUnited States in the past decade and has now reached alarming levels forcertain agents, especially opioid analgesics and stimulants. Thiscategory overlaps with the preceding two in that abuse of prescriptiondrugs, and their non-prescription counterparts, is associated with arange of factors, including dose and co-administration with other drugs.The prevalence of prescription drug abuse among the elderly may be ashigh as 11 percent with an increased risk among women, those who aresocially isolated, subject to depression, and/or have a prior history ofsubstance abuse. Beyond the direct risk to the elderly from PDDA,collateral risk to family members, especially teens and young adults, isgrowing alarmingly. According to the Drug Enforcement Agency,sixty-three percent of teens believe that prescription drugs are easy toget from friends' and family's medicine cabinets, including those oftheir grandparents. As of 2009 there were 7 million Americans aged 12years and older who abused prescription drugs for non-medical purposeseach month, up from 6.2 million in 2008. This represents a 13 percentincrease in a single year. One in seven teens admit to abusingprescription drugs to get high and sixty percent of teens who abusedprescription pain relievers did so before the age of fifteen. The numberof emergency room visits attributable to pharmaceuticals alone is up 97%between 2004 and 2008. According to the Center for Disease Control,prescription drugs, including opioids and antidepressants, areresponsible for more overdose deaths than “street drugs” such ascocaine, heroin, and amphetamines.

Proper disposal of unused prescription drugs has become anotherimportant public health issue as rates of PDDA, accidental poisoning,and the incidence of drugs found in the drinking water have gained moreattention. As a result of the growing public awareness of this problem,and it's potentially deadly effects, local, state and federal entitiesare struggling with efforts to insure the safe distribution and handlingof prescription medications. This includes the disposal of the unusedquantities that typically accumulate in medicine cabinets. Among theseefforts are proposed regulations requiring drug suppliers to collect anddispose of unused drugs, an effort being strongly resisted by the drugindustry due to the complexity and high cost of implementation.

Current solutions have generally failed to address any one of theseproblems adequately, and certainly there are none that address all ofthem. Most focus on the economics of dispensing drugs at the point ofcare in order to facilitate convenience and/or to lower overhead costsfor the distributor. Others, attempt to make drug dispensing moreorganized and manageable, but often result in products that arenightmarish in their complexity to setup, maintain and use. Both ofthese types of solutions also fail to provide the proper point-to-pointsecurity required to avoid drug diversion. Hence, there is a need forimproved methods and systems for efficiently and effectively securing,controlling, and enhancing medication adherence.

BRIEF SUMMARY OF THE INVENTION

Embodiments of the invention provide systems and methods to providesafe, secure and accurate point-to-point delivery of prescription andnon-prescription drugs in the long-term home care or ambulatory careenvironment. More specifically, embodiments of the present inventionprovide for a low-cost, easy-to-use system comprised of a secure drugdispensing unit and medication enclosure combined with wirelessconnectivity and software based on smart mobile phone technology. Suchsystems and methods, referred to herein as a Secure, Control, andEnhance Medication Adherence (SCEMA) system, can mitigate theaforementioned risks associated with the use of prescription andnon-prescription drugs. These risks can be significantly reduced for theelderly in the homecare environment, as well as the general public,without disrupting, or a significantly increasing the cost, to theexisting prescription and non-prescription drug distributioninfrastructure. In addition, the SCEMA system can provide a powerfulplatform for drug research.

According to one embodiment, a medication dispensing unit can comprise aprocessor and a memory coupled with and readable by the processor andstoring a set of instructions which, when executed by the processor,cause the processor to perform a plurality of functions controlling thedispensing of medication from the medication dispensing unit, and one ormore wireless transceivers coupled with the processor. The medicationdispensing unit can be adapted to accept one or more removable, securemedication cartridges preloaded with medication packets and dispense themedication packets from the one or more medication cartridges undercontrol of the plurality of functions. The medication dispensing unitcan further comprise a button coupled with the processor, whereinactuation of the button causes to processor to control execution of oneor more of the plurality of functions. In some cases, the button canfurther comprise a biometric scanner, wherein the biometric scannerreads biometric information from a user of the medication dispensingunit upon actuation of the button, and wherein at least one of theplurality of functions includes authenticating the user based on thebiometric information. In some implementations, the medicationdispensing unit can further comprise a display coupled with theprocessor and wherein one or more of the plurality of functions provideinformation related to the one or more functions through the display.

In use, the medication dispensing can comprise at least one removable,secure medication cartridge installed therein. The medication cartridgecan comprise a memory storing information for the medication dispensingunit. The information can be related to the medication packets preloadedin the medication cartridge and an intended user of the medication. Insuch cases, at least one of the plurality of functions can comprisereading the information related to the medication packets preloaded inthe medication cartridge and the intended user of the medication whenthe medication cartridge is loaded into the medication dispensing unit.In some cases, the medication packets preloaded into the medicationcartridge can comprise a multi-drug regime and one or more of theplurality of functions can support dispensing of the multi-drug regime.Additionally or alternatively, the installed at least one removable,secure medication cartridge can comprise a plurality of installedmedication cartridges and the medications preloaded in each of theplurality of medication cartridges can be different. In suchimplementations, the plurality of functions can include one or morefunctions for changing prescriptions for dispensing the medication basedon the different preloaded medications and instructions received by themedication dispensing unit via the one or more wireless transceivers.Additionally or alternatively, the plurality of functions can includeone or more functions for preventing adverse drug reactions between thedifferent drugs, providing a notification via the one or more wirelesstransceivers when the medication dispensing unit detects a potentialadverse drug reactions, and for receiving via the one or more wirelesstransceivers an override instruction permitting the dispensing ofmedication detected as the potential adverse drug reaction. Similarly,the plurality of functions can include one or more functions forpreventing dispensing of medication in an order, schedule, orcombination that creates a compatibility or interaction problem. In somecases, the medications preloaded in each of the plurality of medicationcartridges can be the same, and the plurality of functions can includeone or more functions for affecting a refill by switching from a primarycartridge for dispensing medication to a secondary cartridge fordispensing medication when the primary cartridge becomes empty.

In some implementations, the plurality of functions can include one ormore functions for providing a reminder to a user of a schedule fortaking the medication based on the information stored in the memory ofthe medication cartridge related to the medication packets preloaded inthe medication cartridge. The plurality of functions may also includeone or more functions for updating the schedule based on instructionsreceived by the medication dispensing unit via the one or more wirelesstransceivers. In some cases, the plurality of functions can include oneor more functions for providing a notification via the one or morewireless transceivers when the medication dispensing unit detects themedication has not been taken as scheduled. Additionally oralternatively, the plurality of functions can include one or morefunctions for providing a refill request via the one or more wirelesstransceivers when the medication dispensing unit detects the medicationpreloaded in the medication cartridge is low.

In some implementations, the medication dispensing unit can comprise atleast one removable, secure medication cartridge installed therein. Themedication cartridge can comprise a memory storing information for themedication dispensing unit. The information can be related to themedication packets preloaded in the medication cartridge and an intendeduser of the medication. The medication cartridge can also comprise and abarcode reader. The barcode reader can read a barcode from themedication packets and the plurality of functions can include functionsfor matching the authenticated user to the medication packets based onthe barcode.

According to another embodiment, a secure medication cartridge cancomprise a container preloaded with medication packets and a feedermechanism within the container adapted to feed the preloaded medicationpackets from the container. The secure medication cartridge can furthercomprise a reader device adapted to read information encoded on themedication packets. The information can be related to and identifyingmedication stored in the medication packets. The secure medicationcartridge can further comprise a memory storing information related tothe medication packets preloaded in the medication cartridge and anintended user of the medication. In some cases, the secure medicationcartridge can further comprising a fluid reservoir within the container.The fluid reservoir can store a liquid, the medication packets can beconstructed of a material that dissolves when exposed to the liquid, andthe fluid reservoir can rupture when the medication cartridge issubjected to tampering. For example, the medication packets can beconstructed of polyvinyl and the fluid can be distilled water.

According to yet another embodiment, a system can comprise a medicationdispensing unit comprising a processor and a memory coupled with andreadable by the processor. The memory can store a set of instructionswhich, when executed by the processor, cause the processor to perform aplurality of functions controlling the dispensing of medication from themedication dispensing unit. The medication dispensing unit can alsocomprise one or more wireless transceivers coupled with the processor,and a button coupled with the processor, wherein actuation of the buttoncauses to processor to control execution of one or more of the pluralityof functions. The button can further comprise a biometric scanner,wherein the biometric scanner reads biometric information from a user ofthe medication dispensing unit upon actuation of the button, and whereinat least one of the plurality of functions includes authenticating theuser based on the biometric information.

The system can also comprise one or more secure medication cartridgesremoveably mounted in the medication dispensing unit. Each one or moresecure medication cartridges can comprise a container preloaded withmedication packets, a feeder mechanism within the container adapted tofeed the preloaded medication packets from the container, a readerdevice adapted to read information encoded on the medication packetsrelated to and identifying medication stored in the medication packets,a memory storing information related to the medication packets preloadedin the medication cartridge and an intended user of the medication, anda fluid reservoir within the container. The fluid reservoir can store aliquid and the medication packets can be constructed of a material thatdissolves when exposed to the liquid. The fluid reservoir can rupturewhen the medication cartridge is subjected to tampering.

The system can further comprising one or more patient devicescommunicatively coupled with the medication dispensing unit via the oneor more wireless transceivers. The one or more patient devices canexecute an application interfacing with the plurality of functionscontrolling the dispensing of medication from the medication dispensingunit. Additionally or alternatively, the system can comprise one or moreservers communicatively coupled with the medication dispensing unit viathe one or more wireless transceivers. The one or more servers canexecute one or more applications interfacing with the plurality offunctions controlling the dispensing of medication from the medicationdispensing unit. Additionally or alternatively, the system can compriseone or more pharmacy systems communicatively coupled with the one ormore servers. The pharmacy system can execute one or more applicationsinterfacing with the plurality of functions controlling the dispensingof medication from the medication dispensing unit. Additionally oralternatively, the system can comprise one or more care provider devicescommunicatively coupled with the medication dispensing unit via the oneor more wireless transceivers. The one or more care provider devices canexecute an application interfacing with the plurality of functionscontrolling the dispensing of medication from the medication dispensingunit.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a block diagram illustrating components of an exemplaryoperating environment in which various embodiments of the presentinvention may be implemented.

FIG. 2 is a block diagram illustrating an exemplary computer system inwhich embodiments of the present invention may be implemented.

FIG. 3 is an illustration of a dispensing unit for use in a system tosecure, control, and enhance medication adherence according to oneembodiment of the present invention.

FIG. 4 is a cross-sectional view illustrating additional details of anexemplary secure medication cartridge for use in a dispensing unit suchas embodied in FIG. 3.

FIG. 5 is a block diagram illustrating, at a high level, elements of asystem to secure, control, and enhance medication adherence according toone embodiment of the present invention.

DETAILED DESCRIPTION OF THE INVENTION

In the following description, for the purposes of explanation, numerousspecific details are set forth in order to provide a thoroughunderstanding of various embodiments of the present invention. It willbe apparent, however, to one skilled in the art that embodiments of thepresent invention may be practiced without some of these specificdetails. In other instances, well-known structures and devices are shownin block diagram form.

The ensuing description provides exemplary embodiments only, and is notintended to limit the scope, applicability, or configuration of thedisclosure. Rather, the ensuing description of the exemplary embodimentswill provide those skilled in the art with an enabling description forimplementing an exemplary embodiment. It should be understood thatvarious changes may be made in the function and arrangement of elementswithout departing from the spirit and scope of the invention as setforth in the appended claims.

Specific details are given in the following description to provide athorough understanding of the embodiments. However, it will beunderstood by one of ordinary skill in the art that the embodiments maybe practiced without these specific details. For example, circuits,systems, networks, processes, and other components may be shown ascomponents in block diagram form in order not to obscure the embodimentsin unnecessary detail. In other instances, well-known circuits,processes, algorithms, structures, and techniques may be shown withoutunnecessary detail in order to avoid obscuring the embodiments.

Also, it is noted that individual embodiments may be described as aprocess which is depicted as a flowchart, a flow diagram, a data flowdiagram, a structure diagram, or a block diagram. Although a flowchartmay describe the operations as a sequential process, many of theoperations can be performed in parallel or concurrently. In addition,the order of the operations may be re-arranged. A process is terminatedwhen its operations are completed, but could have additional steps notincluded in a figure. A process may correspond to a method, a function,a procedure, a subroutine, a subprogram, etc. When a process correspondsto a function, its termination can correspond to a return of thefunction to the calling function or the main function.

The term “machine-readable medium” includes, but is not limited toportable or fixed storage devices, optical storage devices, wirelesschannels and various other mediums capable of storing, containing orcarrying instruction(s) and/or data. A code segment ormachine-executable instructions may represent a procedure, a function, asubprogram, a program, a routine, a subroutine, a module, a softwarepackage, a class, or any combination of instructions, data structures,or program statements. A code segment may be coupled to another codesegment or a hardware circuit by passing and/or receiving information,data, arguments, parameters, or memory contents. Information, arguments,parameters, data, etc. may be passed, forwarded, or transmitted via anysuitable means including memory sharing, message passing, token passing,network transmission, etc.

Furthermore, embodiments may be implemented by hardware, software,firmware, middleware, microcode, hardware description languages, or anycombination thereof. When implemented in software, firmware, middlewareor microcode, the program code or code segments to perform the necessarytasks may be stored in a machine readable medium. A processor(s) mayperform the necessary tasks.

Embodiments of the invention provide systems and methods to providesafe, secure and accurate point-to-point delivery of prescription andnon-prescription drugs in the long-term home care or ambulatory careenvironment. More specifically, embodiments of the present inventionprovide for a low-cost, easy-to-use system comprised of a secure drugdispensing unit and medication enclosure combined with wirelessconnectivity and software based on smart mobile phone technology. Suchsystems and methods, referred to herein as a Secure, Control, andEnhance Medication Adherence (SCEMA) system, can mitigate theaforementioned risks associated with the use of prescription andnon-prescription drugs. These risks can be significantly reduced for theelderly in the homecare environment, as well as the general public,without disrupting, or a significantly increasing the cost, to theexisting prescription and non-prescription drug distributioninfrastructure. In addition, the SCEMA system can provide a powerfulplatform for drug research.

More specifically, a SCEMA dispensing unit according to one embodimentcan operate as a self-contained system that is capable of eithercommunicating directly with a centralized server application, through anon-board cellular communication capabilities, or through another device(wireless router, PC or smart mobile device) via a Blue Tooth or WiFiconnectivity. Use of wireless technology can provide and/or support anumber of functions of a SCEMA system according to various embodimentsincluding but not limited to the maintenance and updating of patientmedication information (i.e. new and expired prescriptions); deliveryand management of secure biometric identification (e.g., electronicallyscanned fingerprints); transmission of audio/visual reminders to theuser, to take their medication on the prescribed schedule; updates ondispensing unit inventory and automatic refill requests; communicationof drug information such as recall or potential adverse reactions;transmission of accelerometer detected attempts to forcibly open orbreech the dispensing unit; localization and tracking of the dispensingunit during transport and/or in the event of diversion; in the event ofdiversion detection, to notify the authorities of the event time andlocation; and/or in the event of diversion or breech, the ability toremotely or automatically render the drugs unusable. Various additionaldetails of embodiments of the present invention will be described belowwith reference to the figures.

FIG. 1 is a block diagram illustrating components of an exemplaryoperating environment in which various embodiments of the presentinvention may be implemented. The system 100 can include one or moreuser computers 105, 110, which may be used to operate a client, whethera dedicate application, web browser, etc. The user computers 105, 110can be general purpose personal computers (including, merely by way ofexample, personal computers and/or laptop computers running variousversions of Microsoft Corp.'s Windows and/or Apple Corp.'s Macintoshoperating systems) and/or workstation computers running any of a varietyof commercially-available UNIX or UNIX-like operating systems (includingwithout limitation, the variety of GNU/Linux operating systems). Theseuser computers 105, 110 may also have any of a variety of applications,including one or more development systems, database client and/or serverapplications, and web browser applications. Alternatively, the usercomputers 105, 110 may be any other electronic device, such as athin-client computer, Internet-enabled mobile telephone, and/or personaldigital assistant, capable of communicating via a network (e.g., thenetwork 115 described below) and/or displaying and navigating web pagesor other types of electronic documents. Although the exemplary system100 is shown with two user computers, any number of user computers maybe supported.

In some embodiments, the system 100 may also include a network 115. Thenetwork may can be any type of network familiar to those skilled in theart that can support data communications using any of a variety ofcommercially-available protocols, including without limitation TCP/IP,SNA, IPX, AppleTalk, and the like. Merely by way of example, the network115 maybe a local area network (“LAN”), such as an Ethernet network, aToken-Ring network and/or the like; a wide-area network; a virtualnetwork, including without limitation a virtual private network (“VPN”);the Internet; an intranet; an extranet; a public switched telephonenetwork (“PSTN”); an infra-red network; a wireless network (e.g., anetwork operating under any of the IEEE 802.11 suite of protocols, theBluetooth protocol known in the art, and/or any other wirelessprotocol); and/or any combination of these and/or other networks such asGSM, GPRS, EDGE, UMTS, 3G, 2.5G, CDMA, CDMA2000, WCDMA, EVDO etc.

The system may also include one or more server computers 120, 125, 130which can be general purpose computers and/or specialized servercomputers (including, merely by way of example, PC servers, UNIXservers, mid-range servers, mainframe computers rack-mounted servers,etc.). One or more of the servers (e.g., 130) may be dedicated torunning applications, such as a business application, a web server,application server, etc. Such servers may be used to process requestsfrom user computers 105, 110. The applications can also include anynumber of applications for controlling access to resources of theservers 120, 125, 130.

The web server can be running an operating system including any of thosediscussed above, as well as any commercially-available server operatingsystems. The web server can also run any of a variety of serverapplications and/or mid-tier applications, including HTTP servers, FTPservers, CGI servers, database servers, Java servers, businessapplications, and the like. The server(s) also may be one or morecomputers which can be capable of executing programs or scripts inresponse to the user computers 105, 110. As one example, a server mayexecute one or more web applications. The web application may beimplemented as one or more scripts or programs written in anyprogramming language, such as Java™, C, C# or C++, and/or any scriptinglanguage, such as Perl, Python, or TCL, as well as combinations of anyprogramming/scripting languages. The server(s) may also include databaseservers, including without limitation those commercially available fromOracle®, Microsoft®, Sybase®, IBM® and the like, which can processrequests from database clients running on a user computer 105, 110.

In some embodiments, an application server may create web pagesdynamically for displaying on an end-user (client) system. The web pagescreated by the web application server may be forwarded to a usercomputer 105 via a web server. Similarly, the web server can receive webpage requests and/or input data from a user computer and can forward theweb page requests and/or input data to an application and/or a databaseserver. Those skilled in the art will recognize that the functionsdescribed with respect to various types of servers may be performed by asingle server and/or a plurality of specialized servers, depending onimplementation-specific needs and parameters.

The system 100 may also include one or more databases 135. Thedatabase(s) 135 may reside in a variety of locations. By way of example,a database 135 may reside on a storage medium local to (and/or residentin) one or more of the computers 105, 110, 115, 125, 130. Alternatively,it may be remote from any or all of the computers 105, 110, 115, 125,130, and/or in communication (e.g., via the network 120) with one ormore of these. In a particular set of embodiments, the database 135 mayreside in a storage-area network (“SAN”) familiar to those skilled inthe art. Similarly, any necessary files for performing the functionsattributed to the computers 105, 110, 115, 125, 130 may be storedlocally on the respective computer and/or remotely, as appropriate. Inone set of embodiments, the database 135 may be a relational database,such as Oracle 10g, that is adapted to store, update, and retrieve datain response to SQL-formatted commands.

FIG. 2 illustrates an exemplary computer system 200, in which variousembodiments of the present invention may be implemented. The system 200may be used to implement any of the computer systems described above.The computer system 200 is shown comprising hardware elements that maybe electrically coupled via a bus 255. The hardware elements may includeone or more central processing units (CPUs) 205, one or more inputdevices 210 (e.g., a mouse, a keyboard, etc.), and one or more outputdevices 215 (e.g., a display device, a printer, etc.). The computersystem 200 may also include one or more storage device 220. By way ofexample, storage device(s) 220 may be disk drives, optical storagedevices, solid-state storage device such as a random access memory(“RAM”) and/or a read-only memory (“ROM”), which can be programmable,flash-updateable and/or the like.

The computer system 200 may additionally include a computer-readablestorage media reader 225 a, a communications system 230 (e.g., a modem,a network card (wireless or wired), an infra-red communication device,etc.), and working memory 240, which may include RAM and ROM devices asdescribed above. In some embodiments, the computer system 200 may alsoinclude a processing acceleration unit 235, which can include a DSP, aspecial-purpose processor and/or the like.

The computer-readable storage media reader 225 a can further beconnected to a computer-readable storage medium 225 b, together (and,optionally, in combination with storage device(s) 220) comprehensivelyrepresenting remote, local, fixed, and/or removable storage devices plusstorage media for temporarily and/or more permanently containingcomputer-readable information. The communications system 230 may permitdata to be exchanged with the network 220 and/or any other computerdescribed above with respect to the system 200.

The computer system 200 may also comprise software elements, shown asbeing currently located within a working memory 240, including anoperating system 245 and/or other code 250, such as an applicationprogram (which may be a client application, web browser, mid-tierapplication, RDBMS, etc.). It should be appreciated that alternateembodiments of a computer system 200 may have numerous variations fromthat described above. For example, customized hardware might also beused and/or particular elements might be implemented in hardware,software (including portable software, such as applets), or both.Further, connection to other computing devices such as networkinput/output devices may be employed. Software of computer system 200may include code 250 for implementing embodiments of the presentinvention as described herein.

As noted above, embodiments of the invention provide systems and methodsto provide safe, secure and accurate point-to-point delivery ofprescription and non-prescription drugs in the long-term home care orambulatory care environment. These embodiments may be implemented inhardware and/or software on any one or more systems such as describedabove. More specifically, embodiments of the present invention comprisea secure drug dispensing unit and medication enclosure combined withwireless connectivity and software based on smart mobile phonetechnology. Such a dispensing unit, also referred to herein as a Secure,Control, and Enhance Medication Adherence (SCEMA) system, can comprise acompact, wirelessly-controlled vessel or medication cartridge that canbe securely sent either to, or returned from, the user's home usingstandard mail or other delivery services with a significantly lower riskof successful breech or diversion. According to one embodiment, thedispensing unit can use biometric identification and secure wirelessnetwork data services to track the location of the unit and, uponreaching its location, dispense the proper medications, in theprescribed manner, time and dose and do so solely to the (biometricallyidentified) authorized user.

Depending upon the implementation, the dispensing unit can of safelystore days, weeks or months of an individual's prescription medicationusing multi-dose medication packaging (when appropriate) or otherpackaging methods to be dispensed when it is being operated by anauthorized user that's been biometrically identified by the system. Insome implementations, the dispensing unit can be equipped withaudiovisual alerts to remind the user when to take their medication andcan be implemented in an variety of form-factors ranging from a smalltravel-size unit to larger desktop units for home or office use, eitherwith or without refrigeration. A user can then seamlessly access any oneof multiple dispensing units (at home, work or during travel) dependingon their needs and location by using their biometric identity. Accordingto one embodiment, a centralized tracking system can prevent duplicatedrug dispensing from occurring for this user when this type ofconfiguration is employed.

According to one embodiment, associated software can be executed by aserver or other computer accessible by a wireless network thatcommunicates with the dispensing device and coordinates and tracksmedication use, security, delivery, refills and adjudicates druginteraction information in order to reduce the incidence of adverse drugreactions. Such a system can permit automated, electronictransaction-based billing for the medications as they are used. Usingsuch a system the user can be billed for the medication as they areused, not upon ordering or receipt of the dispensing vessel, thuseliminating the financial burden of front-loaded drug costs to the user.Using this dispensing strategy, the vessel essentially becomes anextension of the suppliers inventory storage system. The “sale” takesplace upon consumption.

According to one embodiment, a lock-out system comprising anaccelerometer and controlling software within the dispensing unit canengage a physical locking mechanism located on the dispenser. Forexample, the locking mechanism can be engaged by the software of thedispensing unit upon detecting impacts to the dispensing unit suggestingan attempt to forcibly open the unit. Additionally or alternatively, thelocking mechanism can be triggered remotely through wirelesscommunication. For example, it can be triggered by the centralizedcontrol software at any time the accelerometer or the location-trackingsystem indicates that the vessel is being diverted, or there's anattempt to breach the vessel. In some implementations, the vessel ormedication cartridge of the dispensing unit can additionally oralternatively comprises a content disabling mechanism. For example, thismechanism may be provided when storing and dispensing classes of drugsthat are particularly hazardous in the event of diversion and/or with ahigh incidents of diversion. This mechanism can comprise a safe,non-toxic method to render the pharmaceutical contents of the vessel ormedication cartridge unusable in the event of a diversion or an attemptto forcibly open or breach the vessel or medication cartridge. Thedisabling mechanism can be triggered remotely through wirelesscommunication or automatically. It can be triggered by the centralizedcontrol software at any time the accelerometer or the location-trackingsystem indicates that the vessel or medication cartridge is beingdiverted, or there's an attempt to breach the vessel or medicationcartridge.

As noted, a biometrics system of the dispensing unit, such as a fingerswipe reader, or other biometric device, can be employed to provide areliable, compact, low-cost means of secure access to medications storedtherein. The dispensing unit can thus provide for loading and dispensingthe contents of the vessel or medication cartridge once the drug userhas been positively identified using biometrics. It can also be usedduring loading of the vessel or medication cartridge by the drugsupplier or by a caregiver, depending on the class of drug and theassociated risk as well as regulations. For example, during the loadingprocedure the dispensing unit can scan and track the type and quantitiesof pharmaceutical products as they are loaded and verify them againstthe electronically stored prescription details. When dispensing thereverse scanning function takes place and permits information about thetype and dosage of the drug to be displayed on the dispensing unit'sdisplay. Scanning can be accomplished through the use of a 3D barcodescanner embedded in the dispenser or other imaging or sensing methods.

FIG. 3 is an illustration of a dispensing unit for use in a system tosecure, control, and enhance medication adherence according to oneembodiment of the present invention. Generally speaking, the dispensingunit 300 can comprise a wireless device such as any of the devicesdescribed above with reference to FIGS. 1 and 2. That is, the dispensingunit 300 can comprise a processor, memory, and wireless transceiver (notshown here for the sake of clarity) and may execute software to performthe functions described here. As illustrated here, the dispensing unit300 can also include a number of removable vessels or medicationcartridges 305 and 310. As will be seen, these vessels or medicationcartridges 305 and 310 can be pre-loaded by a pharmacy with prescriptionmedication for the user of the dispensing unit 300.

The dispensing unit 300 can also include one or more buttons 315 forinitiating and/or operating dispensing and/or loading functions of thedispensing unit 305. In some cases, the button 315 can comprise ofinclude a biometric reader, such as a fingerprint scanner, to readbiometric information of an operator of the dispensing unit to be usedto authenticate the user before dispensing or loading of medication fromor into the dispensing unit 300. For example, at a scheduled time, analarm may sound through a speaker (not shown here) of the dispensingunit 300. In response, the user can touch the button which may also takea biometric sample to be verified and, assuming the user isauthenticated, a medication packet 325 containing the prescribedmedication 330 to be taken and this scheduled time can be dispensed fromone of the medication cartridges 310 of the dispensing unit 320.

The dispensing unit can also include a display 320 such as an LCD fordisplaying information related to the medication and/or functions of thedispensing unit 300. For example, the display 320 may show a schedulefor dispensing medication, types of medications in the cartridges 305and 310 currently loaded in the dispensing unit 300, an amount ofmedication remaining in the medication cartridges 310, etc. In somecases, the display 320 may comprise a touch screen providing access toother functions and features of the dispensing unit including but notlimited to, setting and silencing alarms, initiating and/or cancelingdispensing and/or loading operations, requesting refills, etc.

However in use a typical use, operation of the dispensing unit 300 canbe reduced to a single user function specifically, placing a finger on asingle button-like surface 315. The other operations that take placeboth before and after that event—from the dispensing unit 300 scanningthe user's fingerprint, matching it to the one in a database, anddispensing the appropriate drugs from the medication cartridge 310,after they are themselves identified by the dispensing unit 300 throughthe data stored, for example, on an encrypted memory chip in thecartridge 310, are invisible to the user. Besides pressing thisdispensing button 315, the user may also need to remove and replace thecartridges 305 and 310 in the dispensing unit 300. The level oftechnical complexity here is also very low, essentially equivalent toinserting or ejecting a video cassette tape or a DVD. But even this taskcan be performed (e.g., for an elderly user) by a professional or familycare giver since a cartridge 305 can be designed to hold up to many daysof medication and since multiple cartridges are employed, so it only hasto been done approximately periodically.

According to one embodiment, other settings and controls can be encodedinto a memory chip embedded into each cartridge 305 and 310. In thisway, the user of the dispensing unit 300 does not need to touch thedisplay 320 or otherwise interact with the dispensing unit 300. Rather,the programming information used by the dispensing unit 300, includingbut not limited to patient identification, prescription details such asdosage and expiration dates, etc., can be stored on the memory chip ofthe medication cartridges 305 and 310 in an encrypted format by thepharmacist or care provider, and can be updated remotely if necessary orappropriate. When a medication cartridge 305 is loaded into thedispensing unit 300 the information on the memory chip of thatmedication cartridge 305 can be read and the information can be used toprogram the actions of the dispensing unit. The patient's electronicfingerprint information can be collected once at the pharmacy or at thecare provider's office, stored as part of the patient's permanent file,and reused for subsequent prescriptions and refills, i.e., to be storedin the memory of the cartridges to identify the intended recipient andthis for control by the dispensing unit 300.

According to one embodiment, the dispensing unit 300 can also supportmulti-drug capabilities for support of dynamic, complex andmulti-provider medication regimens. The use of unit dose packaging inthe cartridges 305 and 310 accommodates complex drug regimens. Suchpackaging equipment permits several different drugs to be placed in asingle packet, and the automated pharmacy equipment permits thepackaging of sequential packets with different regimens in a givencartridge 305 should it be necessary to include additional drugs in twoor more packets. In this case the dispensing unit 300 can dispense theadditional packets in sequence. Also, a multi-cartridge design of thedispensing unit 300 can permit prescription modifications from the same,or other, providers without having to change the initial cartridge. Forexample, if a second, short-term prescription for an antibiotic isordered by a physician it can be added to the patient's drug regimen bydispensing it from a second (third or fourth) cartridge. Long termchanges can be handled in the same way, except that once the primarycartridge's contents is exhausted it can be refilled with the new drugadded to the single packet regimen. Also, multiple cartridges permitsprescription refills prior to the primary cartridge becoming empty. Therefill cartridge can be placed in the dispensing unit 300 but not useduntil the primary is empty. The refill can then become the primary andthe empty can be returned to the pharmacy for refill. This dispensingmanagement can be handled automatically by the dispensing unit 300 bymatching the contents of the individual cartridge(s) with the patient'sprescription and dispensing what is appropriate, avoiding duplicatedispensing, reordering cartridges as they approach empty, and dispensingfrom multiple cartridges when appropriate to fill the orderedprescription(s).

According to one embodiment, the dispensing unit 300 can additionally oralternatively manage prescription and OTC drug compatibility. Theaddition of this capability can be facilitated by the multiple cartridgedesign of the dispensing unit 300 if implemented as such. That is,multiple cartridges can be loaded with prescription and OTC drugs butdispensed only in an order, combination, or on a schedule that does notcreate compatibility or interaction problems. Information foridentifying and managing these compatibility or interaction problems canalso be encoded into the on-board memory of the individual cartridges bythe pharmacy or caregiver before being dispensed.

According to one embodiment, the dispensing unit 300 can additionally oralternatively provide medication reminders to promote medicationadherence. In such cases, automated audio-visual medication reminderscan be delivered by the display 320 on the top of the dispensing unit300 and/or a mobile device that has a software application installedthat enables the mobile device to communicate with the dispensing unitwirelessly, e.g., via Bluetooth, WiFi, etc. The medication reminders canbe programmed through the pharmacy and delivered on the memory chipembedded in the cartridge. In some cases, these reminders can also beremotely updated by the pharmacy wirelessly, e.g., via a cellular, WiFiconnection to the Internet, or other connection, in the event ofprescription changes. In some cases, the audio-visual capabilities ofthe dispensing unit 300 can be used to deliver educational materials andprovide a venue for virtual doctor's visits through the use of textmessaging, voice messaging or live conferences.

According to one embodiment, the dispensing unit 300 can additionally oralternatively provide medication adherence monitoring and keep theprofessional provider/caregiver in the communication “loop.” Asdescribed above, the system is capable of communicating wirelessly withthe pharmacy via a cellular transceiver of the dispensing unit and/orvia a WiFi or other connection from the dispensing unit 300 to theInternet or other communications network. In the event that dispensingunit detects the drugs have not taken as scheduled, the dispensing unit300 can notify either the pharmacist, provider and/or caregiver. Thiscan be accomplished an app loaded on the healthcare provider's or thepharmacist's smart phone, via a text message or email, or thorough othermessages. Another feature that can be incorporated in the dispensingunit 300 to encourage adherence are game-like software features thattrack and score patient's adherence performance over time and offerfeedback and other benefits and awards for top performers.

According to one embodiment, the dispensing unit 300 can additionally oralternatively support delivery validation functions to providepoint-to-point safe and secure medication delivery, refills and returns.In such implementations, the dispensing unit 300 can notify the pharmacyand/or provider or caregiver when a new cartridge 305 is delivered, whenit has been loaded in the dispensing unit 300, when the user dispensesmedication and when the contents of a cartridge 305 is about to beexhausted, and thereby providing an automated refill request. The refillof the cartridge 305 can be safely and effectively accomplished usingthe secure cartridges as described herein. These allow the drug providerto ship a self-address envelop with the cartridge 305. When empty, or atthe end of use (and unused drugs are still contained in the cartridge305) the patient can place the cartridge 305 into the envelope and dropsit in a mailbox. The pharmacy can then refill the cartridge 305 (or theunused drugs are safely disposed of) and the data stored in the memoryof the cartridge 305 can be updated at the pharmacy and the cartridge305 can be returned to the patient by the same method.

According to one embodiment, the dispensing unit 300 can additionally oralternatively provide automated loading and dispensing that allowpharmacy-level expertise to properly provision the system. In suchimplementations, rather than requiring the user, friends and/or familymembers to laboriously load drug dispensing chambers with a complexprescription regimens, the dispensing unit 300 uses the preloadedcartridges 305 and 310 that have been filled by professional pharmacypersonnel using automated packaging systems. This not only preventsmistakes in the drug provisioning process but also prevents drugdiversion and abuse that is a natural byproduct of an open, unsecuredcontainer and manual drug handling and loading in the home.

According to one embodiment, the dispensing unit 300 can additionally oralternatively provide Adverse Drug Reaction (ADR) adjudication functionswhich can comprise an interlock that proactively prevents ADR events andnotifies providers should the system (e.g., using a third party ADRdatabase) detect a potential ADR event. For example, the dispensing unit300 can prevent the dispensing of the offending product(s) and notifythe pharmacist or provider through wireless communication. In themeantime, the dispensing unit 300 can continue to dispense the standardregimen as it awaits updating. In some cases, an authorized pharmacistor provider may over-ride the ADR interlock remotely after the potentialADR case has been reviewed and approved. Facilitating professionaloverriding of these alerts can be provided in cases where clinicalsituations mandate use of drugs with interaction risks (e.g.,spironolactone and ACE inhibitors in heart failure).

According to one embodiment, the dispensing unit 300 can additionally oralternatively provide biometric and barcode confirmation functionsincluding matching the patient with the medication before dispensing.Positive patient identification permits both safe and effect drugdispensing and also prevents accidental (or intentional) multiple doseevents. It also prevents drug diversion and abuse by family members. Thebiometric capabilities of the dispensing unit 300, coupled with theunit's 300 communication abilities, also allows for multi-pointdispensing scenarios. For example, a user can maintain one dispensingunit 300 at home and another in their place of employment. From theperspective of the systems monitoring and/or controlling thesedispensing units, these units can be coupled and viewed as a singledispensing unit, so that drugs dispensed on one unit are not dispensedagain at another. Accordingly, an adherence record can be kept andcontinuously updated and synchronized across multiple systems and users.

According to one embodiment, the dispensing unit 300 can additionally oralternatively provide functions supporting the return of unused drugs.Using the secure cartridges described herein to securely and safelyclose the delivery loop, the safe return of unused or expired drugs tothe pharmacy, or other points of disposal, can be effectivelyaccomplished. As with the automated refill capabilities described above,this feature allows the drug provider to ship a self-address envelopwith the cartridge. At the end of the prescription the patient can placethe cartridge containing the unused contents into the envelope and dropit in a mailbox. Since all of the drugs in the system are tracked usingboth the bar code on the packets and the memory on the cartridge, thesystem can accounted for the doses loaded and dispensed, verses what hasbeen returned.

FIG. 4 is a cross-sectional view illustrating additional details of anexemplary secure medication cartridge for use in a dispensing unit suchas embodied in FIG. 3. Generally speaking, a dispensing unit asdescribed above can comprise the main hardware component of the system.As noted, each dispensing unit can be adapted to accommodate one or moresecure cartridges. These cartridges can serve as secure vessels that cantransport drugs to the patient's home using standard mail or otherdelivery services with a low risk of successful breech or diversion.This same secure cartridge can also permit unused drugs to be returnedto suppliers for safe disposal.

As illustrated here, the cartridge 305 can be preloaded by a pharmacy orother provider with drug packets 325 as described above. The cartridge305 can comprise a feeder mechanism 405 including but not limited to aset of rollers or other mechanisms to provide a controlled feeding ofthe dug packets out of the cartridge 305. The feeder mechanism may bedriven by a motor (not shown here) within the cartridge 305 or withinthe dispensing unit. In other cases, the feeder mechanism 405 may bemanually advanced by the user but locked/unlocked by the cartridge 305and/or dispensing unit under control of the various functions describedherein.

Also as illustrated here, the cartridge 305 can include a barcodescanner 410 or other reader (e.g., an RFID reader). As noted above, eachdose of the drug packets 325 can be marked or encoded with a barcode,RFID transducer, or other identification device. As the drug packet 325doses are fed from the cartridge 305, the barcode reader 410 or otherreader can read the barcode or other identification device and thedispensing unit can use this information to confirm and/or track thedoses dispensed.

As illustrated here, the cartridge 305 can also include a memory 415 orchip. For example, the chip may in some cases comprise a processor aswell as a memory depending upon the exact implementation. As notedabove, the memory 415 of the cartridge 305 can store information used bythe dispensing unit, including but not limited to patientidentification, prescription details such as dosage and expirationdates, etc., in an encrypted format. Such information can be stored inthe memory 415 by the pharmacist or care provider, and can be updatedremotely by the pharmacist or care provide through a wirelesscommunications link of the dispensing unit if necessary or appropriate.When a cartridge 305 is loaded into the dispensing unit the informationon the memory chip 415 of that cartridge 305 can be read and theinformation can be used to program the actions of the dispensing unit.The patient's electronic fingerprint information can be collected onceat the pharmacy or at the care provider's office, stored as part of thepatient's permanent file, and reused for subsequent prescriptions andrefills, i.e., to be stored in the memory 415 of the cartridges 305 toidentify the intended recipient and this for control by the dispensingunit.

According to one embodiment, the cartridge 305 can also be equipped witha drug disabling feature that's triggered by tampering or an attempt tobreach the container. In such embodiments, the cartridge 305 can includea chamber or reservoir 420 within the cartridge 305 filled withdistilled water or other liquid capable of dissolving the drug packets325. This reservoir 420 can be constructed to withstand normal handlingbut also to rupture upon sever shocks or attempts to breech thecartridge 305. This feature can comprise a small, embedded reservoir 420built into an internal compartment within the cartridge 305. Any attemptto force open a cartridge (through cutting, fracturing or prying)results in the breach of this internal reservoir 420 and the release ofthe distilled water or other liquid into the interior of the cartridge305, thereby immersing the unit dose packaged drugs contained within. Assuggested by the illustration here, the reservoir 420 may substantiallyencompass or cover the inside of the cartridge 305 but otherarrangements are contemplated and considered to be within the scope ofthe present invention. Once ruptured, the reservoir 420 releases itscontent and the released water or other liquid then dissolves theplastic packaging of the drug packets 325 and the drugs contained in thepacket, rendering them all but useless.

The reservoir 420 can be considered an optional feature that can beinstalled, for example, on those cartridges designed to dispense drugsthat are at high risk of being diverted and abused (e.g., Schedule IIcontrolled substances). The drug packets 325 to be dispensed from thecartridge can use packaging material, a type of plastic (polyvinyl)commonly used for environmentally friendly consumer product packaging,that dissolves upon contact with water. This material, while highlystable in normal atmospheric moisture and temperature conditions, beginsdissolving rapidly upon contact with liquid water. Using such materials,packet breach, and thereby exposure of the drugs to the water, can occurwithin a few seconds of exposure to distilled water at room temperature(approximately 20 degrees C.). Substantially complete dissolution of thepackage occurs in less than one minute under the same conditions. Theresulting “drug soup” can be retained within the cartridge 305, where itwill have very limited use or value for illicit drug applicationsthereby deterring future attempts to divert drugs in this manner. Safedisposal can then take place at the point of supply.

FIG. 5 is a block diagram illustrating, at a high level, elements of asystem to secure, control, and enhance medication adherence according toone embodiment of the present invention. As noted above, a dispensingunit 300 as described herein can comprise the main component fordelivering medications to the user but can be used within a broadersystem 500 for monitoring, controlling, and tracking of the medicationand its use. The dispensing unit can be communicatively coupled with oneor more other elements of the system 500 via one or more communicationchannels 505 and 510 including but not limited to Bluetooth, WiFi,cellular, etc., depending upon the transceivers built into thedispensing unit 300 for a particular implementation.

For example, the system 500 can include one or more patient devices 515such as a mobile phone, tablet, laptop etc., which can becommunicatively coupled with the dispensing unit 300 through one or moreof the communication channels 505 and 510 such as Bluetooth or WiFi.These one or more devices 515 can execute applications for interfacingwith the functions of the dispensing unit 300 and/or other elements ofthe system 500. For example, through an interface of such an applicationon one or more of these devices 515, a user can receive alarms orreminders, check remaining supplies of medication, request refills,receive and/or set billing information, communicate with a pharmacist orcare provider, etc.

Additionally or alternatively, the dispensing unit 300 can communicatewirelessly with one or more networks 520 and 525 extending beyond theuser's location such a cellular or WiFi connection to the Internet.Through such networks 520 and 525, the dispensing unit 300 cancommunicate with one or more servers 530 executing applications formonitoring, controlling, and tracking of the dispensing unit 300,cartridges 305, and medication packets 325. For example, the server 530can communicate with existing EHR, hospital information systems, and/orpharmacy management systems 535. Together, these systems can supporttracking the dispensing of medication cartridges, tracking the return ofunused portions of those cartridges, tracking the dispensing ofmedications from the dispensing unit, billing for the medicationsdispensed from the dispensing unit, provisioning patient information tothe memory of dispensed medication cartridges, communicating changes orother control functions to the dispensing unit, etc.

Additionally or alternatively, the system 500 can include one or moredevices 540 such as a mobile phone, tablet, laptop etc., used by one ormore pharmacists, care providers, etc. These devices 540 can becommunicatively coupled with the server 530 and/or the pharmacist system535 via any of a variety of available communication channels includingbut not limited to Bluetooth, WiFi, cellular, etc. Generally speaking,these devices 540 can execute one or more applications allowing apharmacist, doctor, or other care provider to interact with thefunctions provided by the server 530, pharmacist system 535, and/or thedispensing unit 300. For example, an application executing on a device540 used by a doctor or other care provider can provide for monitoringuse of the medications of the dispensing unit, providing updates to thedispensing unit 300 and/or pharmacy system 535 for adjusting theprescriptions as dispensed by the dispensing unit 300, etc. In anotherexample, an application executing on a device 540 used by a pharmacistcan provide for monitoring use of the medications of the dispensing unit300, providing updates to the dispensing unit 300 for adjusting theprescriptions as dispensed by the dispensing unit 300, reading biometricinformation from the user of the dispensing unit 300 for provisioningsame to the memory of cartridges dispensed by the pharmacy, etc.

In the foregoing description, for the purposes of illustration, methodswere described in a particular order. It should be appreciated that inalternate embodiments, the methods may be performed in a different orderthan that described. It should also be appreciated that the methodsdescribed above may be performed by hardware components or may beembodied in sequences of machine-executable instructions, which may beused to cause a machine, such as a general-purpose or special-purposeprocessor or logic circuits programmed with the instructions to performthe methods. These machine-executable instructions may be stored on oneor more machine readable mediums, such as CD-ROMs or other type ofoptical disks, floppy diskettes, ROMs, RAMs, EPROMs, EEPROMs, magneticor optical cards, flash memory, or other types of machine-readablemediums suitable for storing electronic instructions. Alternatively, themethods may be performed by a combination of hardware and software.

While illustrative and presently preferred embodiments of the inventionhave been described in detail herein, it is to be understood that theinventive concepts may be otherwise variously embodied and employed, andthat the appended claims are intended to be construed to include suchvariations, except as limited by the prior art.

What is claimed is:
 1. A medication dispensing unit comprising: aprocessor; a memory coupled with and readable by the processor andstoring a set of instructions which, when executed by the processor,cause the processor to perform a plurality of functions controlling thedispensing of medication from the medication dispensing unit; and one ormore wireless transceivers coupled with the processor, wherein themedication dispensing unit is adapted to accept one or more removable,secure medication cartridges preloaded with medication packets anddispense the medication packets from the one or more medicationcartridges under control of the plurality of functions.
 2. Themedication dispensing unit of claim 1, further comprising a buttoncoupled with the processor, wherein actuation of the button causes toprocessor to control execution of one or more of the plurality offunctions.
 3. The medication dispensing unit of claim 2, wherein thebutton further comprises a biometric scanner, wherein the biometricscanner reads biometric information from a user of the medicationdispensing unit upon actuation of the button, and wherein at least oneof the plurality of functions includes authenticating the user based onthe biometric information.
 4. The medication dispensing unit of claim 1,further comprising a display coupled with the processor and wherein oneor more of the plurality of functions provide information related to theone or more functions through the display.
 5. The medication dispensingunit of claim 1, further comprising at least one removable, securemedication cartridge installed therein, the medication cartridgecomprising a memory storing information for the medication dispensingunit, the information related to the medication packets preloaded in themedication cartridge and an intended user of the medication.
 6. Themedication dispensing unit of claim 5, wherein at least one of theplurality of functions comprises reading the information related to themedication packets preloaded in the medication cartridge and theintended user of the medication when the medication cartridge is loadedinto the medication dispensing unit.
 7. The medication dispensing unitof claim 5, wherein the medication packets preloaded into the medicationcartridge comprise a multi-drug regime and wherein one or more of theplurality of functions support dispensing of the multi-drug regime. 8.The medication dispensing unit of claim 5, wherein the installed atleast one removable, secure medication cartridge comprises a pluralityof installed medication cartridges, wherein the medications preloaded ineach of the plurality of medication cartridges are different, andwherein the plurality of functions includes one or more functions forchanging prescriptions for dispensing the medication based on thedifferent preloaded medications and instructions received by themedication dispensing unit via the one or more wireless transceivers. 9.The medication dispensing unit of claim 5, wherein the installed atleast one removable, secure medication cartridge comprises a pluralityof installed medication cartridges, wherein the medications preloaded ineach of the plurality of medication cartridges are different, andwherein the plurality of functions includes one or more functions forpreventing adverse drug reactions, providing a notification via the oneor more wireless transceivers when the medication dispensing unitdetects a potential adverse drug reactions, and for receiving via theone or more wireless transceivers an override instruction permitting thedispensing of medication detected as the potential adverse drugreaction.
 10. The medication dispensing unit of claim 5, wherein theinstalled at least one removable, secure medication cartridge comprisesa plurality of installed medication cartridges, wherein the medicationspreloaded in each of the plurality of medication cartridges are thesame, and wherein the plurality of functions includes one or morefunctions for affecting a refill by switching from a primary cartridgefor dispensing medication to a secondary cartridge for dispensingmedication when the primary cartridge becomes empty.
 11. The medicationdispensing unit of claim 5, wherein the installed at least oneremovable, secure medication cartridge comprises a plurality ofinstalled medication cartridges, wherein the medications preloaded ineach of the plurality of medication cartridges are different, andwherein the plurality of functions includes one or more functions forpreventing dispensing of medication in an order, schedule, orcombination that creates a compatibility or interaction problem.
 12. Themedication dispensing unit of claim 5, wherein the plurality offunctions includes one or more functions for providing a reminder to auser of a schedule for taking the medication based on the informationstored in the memory of the medication cartridge related to themedication packets preloaded in the medication cartridge.
 13. Themedication dispensing unit of claim 12, wherein the plurality offunctions includes one or more functions for updating the schedule basedon instructions received by the medication dispensing unit via the oneor more wireless transceivers.
 14. The medication dispensing unit ofclaim 12, wherein the plurality of functions includes one or morefunctions for providing a notification via the one or more wirelesstransceivers when the medication dispensing unit detects the medicationhas not been taken as scheduled.
 15. The medication dispensing unit ofclaim 12, wherein the plurality of functions includes one or morefunctions for providing a refill request via the one or more wirelesstransceivers when the medication dispensing unit detects the medicationpreloaded in the medication cartridge is low.
 16. The medicationdispensing unit of claim 3, further comprising at least one removable,secure medication cartridge installed therein, the medication cartridgecomprising a memory storing information for the medication dispensingunit, the information related to the medication packets preloaded in themedication cartridge and an intended user of the medication and abarcode reader, wherein the barcode reader reads a barcode from themedication packets and the plurality of functions includes functions formatching the authenticated user to the medication packets based on thebarcode.
 17. A secure medication cartridge comprising: a containerpreloaded with medication packets; and a feeder mechanism within thecontainer adapted to feed the preloaded medication packets from thecontainer.
 18. The secure medication cartridge of claim 17, furthercomprising a reader device adapted to read information encoded on themedication packets, the information related to and identifyingmedication stored in the medication packets.
 19. The secure medicationcartridge of claim 17, further comprising a memory storing informationrelated to the medication packets preloaded in the medication cartridgeand an intended user of the medication.
 20. The secure medicationcartridge of claim 17, wherein the medication packets are constructed ofpolyvinyl and the fluid is distilled water.
 21. A system for comprising:a medication dispensing unit comprising a processor, a memory coupledwith and readable by the processor and storing a set of instructionswhich, when executed by the processor, cause the processor to perform aplurality of functions controlling the dispensing of medication from themedication dispensing unit, one or more wireless transceivers coupledwith the processor, and a button coupled with the processor, whereinactuation of the button causes to processor to control execution of oneor more of the plurality of functions, wherein the button furthercomprises a biometric scanner, wherein the biometric scanner readsbiometric information from a user of the medication dispensing unit uponactuation of the button, and wherein at least one of the plurality offunctions includes authenticating the user based on the biometricinformation; and one or more secure medication cartridges removeablymounted in the medication dispensing unit, each one or more securemedication cartridges comprising a container preloaded with medicationpackets, a feeder mechanism within the container adapted to feed thepreloaded medication packets from the container, a reader device adaptedto read information encoded on the medication packets, the informationrelated to and identifying medication stored in the medication packets,a memory storing information related to the medication packets preloadedin the medication cartridge and an intended user of the medication, anda fluid reservoir within the container, wherein the fluid reservoirstores a liquid, wherein the medication packets are constructed of amaterial that dissolves when exposed to the liquid, and wherein thefluid reservoir ruptures when the medication cartridge is subjected totampering.
 22. The system of claim 21, further comprising one or morepatient devices communicatively coupled with the medication dispensingunit via the one or more wireless transceivers, the one or more patientdevices executing an application interfacing with the plurality offunctions controlling the dispensing of medication from the medicationdispensing unit.
 23. The system of claim 21, further comprising one ormore servers communicatively coupled with the medication dispensing unitvia the one or more wireless transceivers, the one or more serversexecuting one or more applications interfacing with the plurality offunctions controlling the dispensing of medication from the medicationdispensing unit.
 24. The system of claim 23, further comprising one ormore pharmacy systems communicatively coupled with the one or moreservers and executing one or more applications interfacing with theplurality of functions controlling the dispensing of medication from themedication dispensing unit.
 25. The system of claim 21, furthercomprising one or more care provider devices communicatively coupledwith the medication dispensing unit via the one or more wirelesstransceivers, the one or more care provider devices executing anapplication interfacing with the plurality of functions controlling thedispensing of medication from the medication dispensing unit.